Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays

Jessica Marie Louise Fogel, Estelle Piwowar-Manning, Barbara Debevec, Tamara Walsky, Katherine Schlusser, Oliver B. Laeyendecker, Ethan A. Wilson, Marybeth McCauley, Theresa Gamble, Gerald Tegha, Dean Soko, Johnstone Kumwenda, Mina C. Hosseinipour, Ying Q. Chen, Myron S. Cohen, Susan Eshleman

Research output: Contribution to journalArticle

Abstract

Background: Antiretroviral therapy (ART) can downregulate antibody responses to HIV infection. We evaluated the impact of early vs. delayed ART on the performance of HIV diagnostic and incidence assays. Methods: Samples were obtained from 207 participants in the HPTN 052 trial, who were stably suppressed on ART for ≥4 years [Malawi sites; pre-ART CD4 cell count 350-550 cells/mm3 (early ART arm, N = 180) or <250 cells/mm3 or an AIDS-defining illness (delayed ART arm, N = 27)]. Samples were tested with 2 HIV rapid tests and 2 HIV incidence assays; selected samples were also tested with two fourth-generation immunoassays and a Western blot (WB) assay. A pre-ART sample was analyzed if the follow-up sample had a false-negative or weakly-reactive rapid test result, or had an incidence assay result indicative of recent infection (false-recent result). Results: Ten (4.8%) samples had a nonreactive or weakly-reactive rapid test result (7/180 early ART arm, 3/27 delayed ART arm, P = 0.13); one sample had nonreactive fourth-generation assay results and 3 had indeterminate WBs. Forty (18.9%) samples had a false-recent incidence assay result; 16 (7.8%) had false-recent results with both incidence assays. Baseline samples had stronger rapid test and WB bands, higher fourth-generation assay signal-to-cutoff values, and fewer HIV incidence assay results indicative of recent infection. Conclusions: False-negative/weakly-reactive HIV rapid tests and false-recent HIV incidence assay results were observed in virally-suppressed individuals, regardless of pre-ART CD4 cell count. Downregulation of the antibody response to HIV infection in the setting of ART may impact population-level surveys of HIV prevalence and incidence.

Original languageEnglish (US)
Pages (from-to)426-430
Number of pages5
JournalJournal of Acquired Immune Deficiency Syndromes
Volume75
Issue number4
DOIs
StatePublished - Aug 1 2017

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Secondary Prevention
HIV
Incidence
HIV-2
Therapeutics
CD4 Lymphocyte Count
HIV Infections
Antibody Formation
Down-Regulation
Western Blotting
Malawi
Infection
Immunoassay
Acquired Immunodeficiency Syndrome

Keywords

  • early ART
  • HIV incidence assays
  • HIV rapid tests
  • HPTN 052
  • suppressive ART

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Brief Report : Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays. / Fogel, Jessica Marie Louise; Piwowar-Manning, Estelle; Debevec, Barbara; Walsky, Tamara; Schlusser, Katherine; Laeyendecker, Oliver B.; Wilson, Ethan A.; McCauley, Marybeth; Gamble, Theresa; Tegha, Gerald; Soko, Dean; Kumwenda, Johnstone; Hosseinipour, Mina C.; Chen, Ying Q.; Cohen, Myron S.; Eshleman, Susan.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 75, No. 4, 01.08.2017, p. 426-430.

Research output: Contribution to journalArticle

Fogel, JML, Piwowar-Manning, E, Debevec, B, Walsky, T, Schlusser, K, Laeyendecker, OB, Wilson, EA, McCauley, M, Gamble, T, Tegha, G, Soko, D, Kumwenda, J, Hosseinipour, MC, Chen, YQ, Cohen, MS & Eshleman, S 2017, 'Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays', Journal of Acquired Immune Deficiency Syndromes, vol. 75, no. 4, pp. 426-430. https://doi.org/10.1097/QAI.0000000000001421
Fogel, Jessica Marie Louise ; Piwowar-Manning, Estelle ; Debevec, Barbara ; Walsky, Tamara ; Schlusser, Katherine ; Laeyendecker, Oliver B. ; Wilson, Ethan A. ; McCauley, Marybeth ; Gamble, Theresa ; Tegha, Gerald ; Soko, Dean ; Kumwenda, Johnstone ; Hosseinipour, Mina C. ; Chen, Ying Q. ; Cohen, Myron S. ; Eshleman, Susan. / Brief Report : Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays. In: Journal of Acquired Immune Deficiency Syndromes. 2017 ; Vol. 75, No. 4. pp. 426-430.
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abstract = "Background: Antiretroviral therapy (ART) can downregulate antibody responses to HIV infection. We evaluated the impact of early vs. delayed ART on the performance of HIV diagnostic and incidence assays. Methods: Samples were obtained from 207 participants in the HPTN 052 trial, who were stably suppressed on ART for ≥4 years [Malawi sites; pre-ART CD4 cell count 350-550 cells/mm3 (early ART arm, N = 180) or <250 cells/mm3 or an AIDS-defining illness (delayed ART arm, N = 27)]. Samples were tested with 2 HIV rapid tests and 2 HIV incidence assays; selected samples were also tested with two fourth-generation immunoassays and a Western blot (WB) assay. A pre-ART sample was analyzed if the follow-up sample had a false-negative or weakly-reactive rapid test result, or had an incidence assay result indicative of recent infection (false-recent result). Results: Ten (4.8{\%}) samples had a nonreactive or weakly-reactive rapid test result (7/180 early ART arm, 3/27 delayed ART arm, P = 0.13); one sample had nonreactive fourth-generation assay results and 3 had indeterminate WBs. Forty (18.9{\%}) samples had a false-recent incidence assay result; 16 (7.8{\%}) had false-recent results with both incidence assays. Baseline samples had stronger rapid test and WB bands, higher fourth-generation assay signal-to-cutoff values, and fewer HIV incidence assay results indicative of recent infection. Conclusions: False-negative/weakly-reactive HIV rapid tests and false-recent HIV incidence assay results were observed in virally-suppressed individuals, regardless of pre-ART CD4 cell count. Downregulation of the antibody response to HIV infection in the setting of ART may impact population-level surveys of HIV prevalence and incidence.",
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AU - Schlusser, Katherine

AU - Laeyendecker, Oliver B.

AU - Wilson, Ethan A.

AU - McCauley, Marybeth

AU - Gamble, Theresa

AU - Tegha, Gerald

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